台灣璞氏健康發展有限公司

Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career. - Office Based in Taipei The scope of responsibilities will include: - REGULATORY AFFAIRS • Develop reasonable project timelines (regulatory and ethics committee aspects) • Liaise with project team to procure documents necessary for regulatory and IRB submissions, with review to ensure meeting local requirements • Prepare submission dossiers (coordinating translations & proofreading, compiling the dossier) within planned timelines and submit to the authority and ethics committee • Prepare applications for import and export licenses, where applicable. • Maintain regulatory study lifecycle, manage changes in the study as applicable (by means of submitting notifications/supplemental applications) • Deliver regulatory training to project teams • Assist with feasibility research and business development requests -SAFETY MANAGEMENT • Manage safety reporting to authorities

Take your career to the next level and lead challenging study activation process on a country/regional level. You will support clinical research teams and ensure PSI projects start smoothly and on time. - Office based in Taipei You will: • Maintains study-specific and corporate startup tracking systems • Facilitates site budgets and contract negotiations • Supports site regulatory document collection • Under supervision, may prepare initial submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable) • Communicates with the project team and investigational sites throughout the study startup phase • Develops site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestones • May review study specific translations • Supervises Trial Master File (TMF) maintenance throughout the study startup phase

As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them. This position is based in Taipei. Responsibilities: • Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters • Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations • Review and analysis of clinical data to ensure the safety of study participants in clinical studies • Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments • Address safety issues across the study from sites and the study team • Review listings for coded events to verify Medical Dictionary for Regulatory activities • Participate in bid defense meetings • Assist in Pharmacovigilance activities • Identify Program risks, and create and implement mitigation strategies with Clinical Operations • Ability to organise and lead clinical development advisory boards and safety monitoring boards • Ensure Study team compliance with local regulatory agencies, ICH and GCP guidelines • Review and sign off clinical documents with respect to medical relevance